BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3000357 · Received March 12, 2013

    Report

    Report Number
    1416980-2013-05919
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER, HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF CRACKED TRANSFER SET TUBING, PERITONITIS, AND PATIENT DEATH. ON AN UNREPORTED DATE, THE PATIENT HAD A CRACK IN THEIR TRANSFER SET TUBING, WHICH CAUSED PERITONITIS MANIFESTED BY CLOUDY DRAIN. TWO DAYS LATER, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST; HOWEVER, IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE PATIENT WAS NOT HOSPITALIZED PRIOR TO DEATH. TREATMENT WAS NOT REPORTED AND IT WAS NOT REPORTED IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS PRIOR TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103752 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death HEPARIN| DIANEAL PD2 1.5%